Metabolic Dysfunction-Associated Steatotic Liver Disease Infant DevelopmentPhase 2MILK-HI-TUDCANCT07517276
TUDCA in High-Risk Lactating Mothers Identified by Early Postpartum Milk Hydrophobicity Index
A Phase 2 study testing tauroursodeoxycholic acid (TUDCA) in people with Metabolic Dysfunction-Associated Steatotic Liver Disease Infant Development, run by Peking University First Hospital.
Trial summary
This is a randomized, double-blind, placebo-controlled Phase 2 proof-of-concept trial in mother-infant dyads. The study aims to evaluate the safety, tolerability, and biological effects of maternal oral tauroursodeoxycholic acid (TUDCA) in lactating mothers with metabolic dysfunction-associated steatotic liver disease… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Metabolic Dysfunction-Associated Steatotic Liver Disease Infant Development
- What is being tested?
- tauroursodeoxycholic acid (TUDCA)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 2 Apr 2026to 30 Jul 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Lactating mother aged 18 to 45 years
- Within 72 hours after delivery at screening
- Intention to continue breastfeeding or providing expressed breast milk during the treatment period
- Maternal metabolic dysfunction-associated steatotic liver disease (MASLD) defined by protocol-specified clinical criteria
- Early postpartum breast milk sample meeting the predefined high-risk bile acid hydrophobicity index threshold
- Live-born infant considered clinically stable and eligible for enteral feeding
- Ability and willingness to provide written informed consent for maternal participation and infant-related study procedures
Who cannot join
- Maternal chronic liver disease other than MASLD, decompensated liver disease, biliary obstruction, acute cholecystitis, or pancreatitis
- Current use of ursodeoxycholic acid, tauroursodeoxycholic acid, or another protocol-prohibited bile acid-modifying medication
- Maternal severe renal insufficiency or other clinically significant condition judged by the investigator to increase study risk
- Preterm infant less than 37 weeks of gestation or birth weight less than 2500 g
- Major congenital anomaly or infant condition requiring ongoing intensive care at enrollment
- Any condition that, in the investigator's judgment, makes the mother-infant dyad unsuitable for participation
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial of Maternal Oral TUDCA in High-Risk Lactating Mother-Infant Dyads Identified by Early Postpartum Breast Milk Bile Acid Hydrophobicity Index
This is a randomized, double-blind, placebo-controlled Phase 2 proof-of-concept trial in mother-infant dyads. The study aims to evaluate the safety, tolerability, and biological effects of maternal oral tauroursodeoxycholic acid (TUDCA) in lactating mothers with metabolic dysfunction-associated steatotic liver disease (MASLD).
Eligible mother-infant dyads will be screened in the early postpartum period using breast milk bile acid hydrophobicity index. Dyads identified as high risk will be randomized 1:1 to maternal oral TUDCA or placebo.
The primary objectives are to assess maternal and infant safety and to evaluate changes in breast milk bile acid hydrophobicity index. Secondary objectives include assessment of infant ketone-related metabolic biomarkers and gut microbiome features. Exploratory outcomes include early infant neurodevelopment during follow-up.
Read the detailed description
This is a single-center, randomized, double-blind, placebo-controlled Phase 2 interventional study conducted in lactating mother-infant dyads.
Mothers with metabolic dysfunction-associated steatotic liver disease (MASLD) will be screened in the early postpartum period. Breast milk samples collected within the first days after delivery will be analyzed to determine bile acid hydrophobicity index. Dyads meeting a predefined high-risk threshold will be enrolled and randomized in a 1:1 ratio to receive either maternal oral tauroursodeoxycholic acid (TUDCA) or matching placebo.
Study treatment will be administered during the early postpartum period for a defined duration. The primary endpoints include maternal and infant safety and tolerability, as well as changes in breast milk bile acid hydrophobicity index. Secondary endpoints include infant serum beta-hydroxybutyrate levels and gut microbiome features. Exploratory endpoints include early neurodevelopmental outcomes during follow-up.
This study aims to provide proof-of-concept evidence for a mechanism-based intervention targeting maternal milk composition to influence early-life metabolic and developmental pathways.
- Being tested
- tauroursodeoxycholic acid (TUDCA), Placebo
- Keywords
- TUDCA, tauroursodeoxycholic acid, breast milk bile acids, hydrophobicity index, beta-hydroxybutyrate, gut microbiome, mother-infant dyad, MASLD, neurodevelopment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tauroursodeoxycholic acid (TUDCA)Drug
Also called TUDCA
Maternal oral tauroursodeoxycholic acid administered according to the protocol-defined dose and schedule during the early postpartum period.
PlaceboDrug
Also called Matching placebo
Matching maternal oral placebo administered according to the same schedule as the experimental arm during the early postpartum period.
| Study group | Role | What they receive |
|---|---|---|
| Maternal Oral TUDCA | Experimental | High-risk mother-infant dyads randomized to this arm will receive maternal oral tauroursodeoxycholic acid (TUDCA) during the early postpartum period in addition to standard postpartum care and breastfeeding support. Receives: Drug: tauroursodeoxycholic acid (TUDCA) |
| Maternal Oral Placebo | Placebo comparator | High-risk mother-infant dyads randomized to this arm will receive matching maternal oral placebo during the early postpartum period in addition to standard postpartum care and breastfeeding support. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of maternal treatment-emergent adverse events
Number of lactating mothers with treatment-emergent adverse events, serious adverse events, treatment discontinuation, or clinically significant safety findings during the study period.
Measured: Baseline to Day 28
Incidence of infant treatment-emergent adverse events
Number of infants with clinically significant adverse events, feeding intolerance, vomiting, diarrhea, jaundice requiring treatment, hospitalization, or other protocol-defined safety events during follow-up.
Measured: Birth to Day 28
Change in breast milk bile acid hydrophobicity index
Change from baseline in breast milk bile acid hydrophobicity index measured by targeted liquid chromatography-mass spectrometry.
Measured: Baseline to Day 7
Secondary outcomes (4)
Infant serum beta-hydroxybutyrate concentration
Infant serum beta-hydroxybutyrate concentration measured during follow-up.
Measured: Day 7 and Day 14
Infant stool microbiome features
Changes in infant stool microbiome composition and predefined microbial features during follow-up.
Measured: Day 7 and Day 14
Breast milk bile acid composition
Breast milk bile acid composition measured using targeted metabolomic profiling.
Measured: Baseline, Day 7, and Day 14
Early infant neurodevelopmental screening score
Exploratory early infant neurodevelopmental assessment using a protocol-defined developmental screening tool.
Measured: 3 months after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2026
- Study start2 Apr 2026 (estimated)
- Primary completion30 May 2026 (estimated)
- Study completion30 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic Dysfunction-Associated Steatotic Liver Disease Infant DevelopmentStudies of the same condition, open and under way.
- More trials run by Peking University First HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University First Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yuhang Zhang, MD, PhD, Principal investigator, Peking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07517276
- Sponsor's protocol ID
- PKUFH-MASLD-MILKHI-2026-01
- Acronym
- MILK-HI-TUDCA
- Status last verified
- Apr 2026
- First submitted
- 1 Apr 2026
- Last updated
- 8 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial of Maternal Oral TUDCA in High-Risk Lactating Mother-Infant Dyads Identified by Early Postpartum Breast Milk Bile Acid Hydrophobicity Index
- ClinicalTrials.gov ID
- NCT07517276
- Acronym / sponsor ID
- MILK-HI-TUDCA / PKUFH-MASLD-MILKHI-2026-01
- Keywords
- TUDCA, tauroursodeoxycholic acid, breast milk bile acids, hydrophobicity index, beta-hydroxybutyrate, gut microbiome, mother-infant dyad, MASLD
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Peking University First HospitalUniversity, hospital or other
- Study start
- 2 Apr 2026 (estimated)
- Primary completion
- 30 May 2026 (estimated)
- Study completion
- 30 Jul 2026 (estimated)
- First posted
- 8 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized, double-blind, placebo-controlled Phase 2 proof-of-concept trial in mother-infant dyads. The study aims to evaluate the safety, tolerability, and biological effects of maternal oral tauroursodeoxycholic acid (TUDCA) in lactating mothers with metabolic dysfunction-associated steatotic liver disease (MASLD).
Eligible mother-infant dyads will be screened in the early postpartum period using breast milk bile acid hydrophobicity index. Dyads identified as high risk will be randomized 1:1 to maternal oral TUDCA or placebo.
The primary objectives are to assess maternal and infant safety and to evaluate changes in breast milk bile acid hydrophobicity index. Secondary objectives include assessment of infant ketone-related metabolic biomarkers and gut microbiome features. Exploratory outcomes include early infant neurodevelopment during follow-up.
Detailed description
This is a single-center, randomized, double-blind, placebo-controlled Phase 2 interventional study conducted in lactating mother-infant dyads.
Mothers with metabolic dysfunction-associated steatotic liver disease (MASLD) will be screened in the early postpartum period. Breast milk samples collected within the first days after delivery will be analyzed to determine bile acid hydrophobicity index. Dyads meeting a predefined high-risk threshold will be enrolled and randomized in a 1:1 ratio to receive either maternal oral tauroursodeoxycholic acid (TUDCA) or matching placebo.
Study treatment will be administered during the early postpartum period for a defined duration. The primary endpoints include maternal and infant safety and tolerability, as well as changes in breast milk bile acid hydrophobicity index. Secondary endpoints include infant serum beta-hydroxybutyrate levels and gut microbiome features. Exploratory endpoints include early neurodevelopmental outcomes during follow-up.
This study aims to provide proof-of-concept evidence for a mechanism-based intervention targeting maternal milk composition to influence early-life metabolic and developmental pathways.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Maternal Oral TUDCA | Experimental | Drug: tauroursodeoxycholic acid (TUDCA)High-risk mother-infant dyads randomized to this arm will receive maternal oral tauroursodeoxycholic acid (TUDCA) during the early postpartum period in addition to standard postpartum care and breastfeeding support. |
| Maternal Oral Placebo | Placebo comparator | Drug: PlaceboHigh-risk mother-infant dyads randomized to this arm will receive matching maternal oral placebo during the early postpartum period in addition to standard postpartum care and breastfeeding support. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Lactating mother aged 18 to 45 years
- Within 72 hours after delivery at screening
- Intention to continue breastfeeding or providing expressed breast milk during the treatment period
- Maternal metabolic dysfunction-associated steatotic liver disease (MASLD) defined by protocol-specified clinical criteria
- Early postpartum breast milk sample meeting the predefined high-risk bile acid hydrophobicity index threshold
Key exclusion criteria (6 listed)
- Maternal chronic liver disease other than MASLD, decompensated liver disease, biliary obstruction, acute cholecystitis, or pancreatitis
- Current use of ursodeoxycholic acid, tauroursodeoxycholic acid, or another protocol-prohibited bile acid-modifying medication
- Maternal severe renal insufficiency or other clinically significant condition judged by the investigator to increase study risk
- Preterm infant less than 37 weeks of gestation or birth weight less than 2500 g
- Major congenital anomaly or infant condition requiring ongoing intensive care at enrollment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tauroursodeoxycholic acid (TUDCA)Also: TUDCAMaternal oral tauroursodeoxycholic acid administered according to the protocol-defined dose and schedule during the early postpartum period. | Drug | Maternal Oral TUDCA |
| PlaceboAlso: Matching placeboMatching maternal oral placebo administered according to the same schedule as the experimental arm during the early postpartum period. | Drug | Maternal Oral Placebo |
Primary outcome
Incidence of maternal treatment-emergent adverse events
Time frame: Baseline to Day 28
Number of lactating mothers with treatment-emergent adverse events, serious adverse events, treatment discontinuation, or clinically significant safety findings during the study period.
Incidence of infant treatment-emergent adverse events
Time frame: Birth to Day 28
Number of infants with clinically significant adverse events, feeding intolerance, vomiting, diarrhea, jaundice requiring treatment, hospitalization, or other protocol-defined safety events during follow-up.
Change in breast milk bile acid hydrophobicity index
Time frame: Baseline to Day 7
Change from baseline in breast milk bile acid hydrophobicity index measured by targeted liquid chromatography-mass spectrometry.
4 secondary outcomes
Infant serum beta-hydroxybutyrate concentration
Time frame: Day 7 and Day 14
Infant stool microbiome features
Time frame: Day 7 and Day 14
Breast milk bile acid composition
Time frame: Baseline, Day 7, and Day 14
Early infant neurodevelopmental screening score
Time frame: 3 months after birth
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2026.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yuhang Zhang, MD, PhD principal investigator
Peking University First Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing tauroursodeoxycholic acid (TUDCA) in people with Metabolic Dysfunction-Associated Steatotic Liver Disease Infant Development, run by Peking University First Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yuhang Zhang (86-010-83950400, yuhang@pkufh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of maternal treatment-emergent adverse events (time frame: Baseline to Day 28). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2026.